MAUDE Adverse Event Report: HEART VALVES SANTA ANA MELODY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number PB1018

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: pb1018, serial/lot #: (b)(4), ubd: 10-feb-2022, udi#: (b)(4).Product analysis: the device remains implanted; therefore, no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of a transcatheter pulmonary bioprosthetic valve, two valves were implanted i n the pulmonary position due to patient anatomy.It was reported the patient's main pulmonary artery was too big for a transcatheter valve and the branch pulmonary artery was so dilated it required two valves be implanted adjacent to each other.No additional adverse patient effects were reported.

Manufacturer Narrative

Conclusion: a device history review (dhr) review is not required as the product event does not indicate a potential manufacturing issue.There is no information to suggest and allege a device quality deficiency that may have caused or contributed to this event.From the information received both valves remain implanted.Per melody instructions for use (ifu), indications for use, it states, ¿the melody¿ tpv is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (rvot) conduit or surgical bioprosthetic pulmonary valve that has = moderate regurgitation, and/or a mean rvot gradient =35 mm hg.¿ medtronic has not submitted the melody for any design related testing for patients who require replacement of their native pulmonary valve with two melody valves implanted side-by-side nor does medtronic have any data to support the use of two melody valves in the pulmonary position side-by-side.It was noted that the physician was aware the way he implanted the melody valves was off label use.This event does not indicate a device malfunction or failure to meet manufacturing specifications.No further action is recommended.Medtronic will continue to monitor field performance for similar events should they occur.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received that prior to the transcatheter aortic valve replacement (tavr) procedure, the physician intentionally planned to implant two valves adjacent to each other due to the uniquely large native valve annulus.During the tavr procedure, the first valve was implanted immediately followed by the second valve; both valves are active, side-by-side in the pulmonary position.The physician was aware this was off-label use.No additional adverse patient effects were reported.H6.Patient code updated.Device code added.Eval code-conclusion updated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of a transcatheter pulmonary bioprosthetic valve, two valves (d164242 and d33 2035) were implanted in the pulmonary position due to patient anatomy.It was reported the patient's main pulmonary artery was too big for a transcatheter valve and the branch pulmonary artery was so dilated it required two valves be implanted adjacent to each other.No additional adverse patient effects were reported.Additional information was received that due to the uniquely large native valve annulus, the transcatheter aortic valve replacement (tavr) procedure was planned with the intent to implant two valves adjacent to each other.The first valve (d164242) was implanted followed by the second valve (d332035); both valves are active in the pulmonary position.The physician was aware this was off-label use.No adverse patient effects were reported.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10515015
• MDR Text Key: 206343811
• Report Number: 2025587-2020-02790
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00643169588196
• UDI-Public: 00643169588196
• Combination Product (y/n): N
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2021
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/20/2020; 10/20/2020
• Supplement Dates FDA Received: 10/21/2020; 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 98